Vaginal Prolapse Surgeries Are Equally Effective

Lara C. Pullen, PhD

March 11, 2014

Two widely used native tissue transvaginal approaches for apical prolapse are equally safe and effective at 2 years. Uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) yield comparable outcomes for the treatment of prolapse and stress urinary incontinence. However, the study has also found that perioperative pelvic floor muscle training (BPMT) does not improve urinary symptoms at 6 months or prolapse outcomes at 2 years after subsequent surgery.

Pelvic organ prolapse results when vaginal walls protrude beyond the vaginal opening or the uterus descends into the lower vagina. More than 300,000 women are treated each year in the United States for pelvic organ prolapse.

Mathew D. Barber, MD, MHS, from Obstetrics/Gynecology and Women’s Health Institute, Cleveland Clinic, Ohio, and colleagues published the results of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) randomized trial in the March 12 issue of JAMA. The trial included 374 women with either uterine or posthysterectomy vault prolapse. The 2 × 2 factorial randomized trial was conducted between 2008 and 2013 in 9 medical centers in the United States.

Women were randomly assigned to receive SSLF (n = 186) or ULS (n = 188) and to receive BPMT (n = 186) or usual care (n = 188). BPMT was provided by clinicians who were certified after rigorous in-person testing.

At 2 years, 84.5% participants were available for follow-up. Success was defined by a composite of anatomic results, patient-reported symptoms, and retreatment. The outcome assessors were blinded to the surgical intervention.

The surgical success rates were 59.2% (93/157) for ULS and 60.5% (92/152) for SSLF (unadjusted difference, −1.3% [95% confidence interval (CI), −12.2% to 9.6%]; adjusted odds ratio, 0.9 [95% CI, 0.6 - 1.5], respectively). The results also suggest that both ULS and SSLF treatments are safe, with equally low rates of serious adverse events (16.5% for ULS vs 16.7% for SSLF; unadjusted difference,−0.2%; 95% CI, −7.7% - 7.4%; adjusted odds ratio, 0.9; 95% CI, 0.5 - 1.6). The data also provide a metric by which to judge other vaginal procedures, according to the authors.

BPMT is an effective stand-alone therapy for incontinence, 1 of the symptoms of pelvic organ prolapse. The lack of effect of perioperative BPMT in this study, however, adds to the body of literature on the effects of BPMT. Some studies have found BPMT to be ineffective in this patient group, and others have seen improved outcomes with perioperative BPMT.

The authors were surprised to find that women who received BPMT and ULS had greater apical descent (23.0%) than those who received BPMT and SSLF (12.0%) or ULS and usual care (8.6%).

This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Dr. Barber has received a research grant from the Foundation for Female Health Awareness and royalties from UptoDate and Elsevier. One coauthor has reported having received royalties from UptoDate. One coauthor has reported having received a research grant from Pfizer and being a consultant for Pfizer and Astellas. One coauthor has reported having received research grants from Astellas, the University of California/Pfizer, and Pfizer; being a consultant for the Astellas Advisory Board, GlaxoSmithKline, Uromedica, IDEO, and Xanodyne; and receiving an education grant from Warner Chilcott. One coauthor has reported having received a research grant from Renew Medical and an educational grant from Ethicon/Johnson & Johnson; being a consultant for Pfizer, Renew Medical, and American Medical Systems; and receiving payment for the development of educational content for Sharp Chula Vista. One coauthor has reported having received research support from Boston Scientific, being a consultant for Ferring Pharmaceuticals, serving on an advisory board and a speakers bureau for Astellas and Cadence Pharmaceuticals, and receiving royalties from McGraw-Hill. One coauthor has reported having received a research grant from Pfizer and serving as a consultant for Astellas.

JAMA. 2014;311:1023-1034. Abstract

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